A Day in the Life of a Senior Quality Officer- Validation
Leads team and provides support for new product introduction, new equipment and computer system introduction in line with regulatory requirements, corporate policies and site SOP’s.
Collaborates with both local and global project teams to assure quality of all validation activities performed at site to support release of medicinal products.
Sets priorities of team to ensure all validation activities are planned.
Coordinates and supervises team to ensure maintenance of validated status of site WRT Cleaning/packing/process validation/temperature mapping.
Provides coaching to team members to achieve individual and site goals.
Ensures planning schedules are met in order to achieve customer service.
Performs/leads audit and inspection readiness preparation to meet HPRA, FDA, Regulatory requirements. Provides support in resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Participating/leading CI activities/ Projects/ Root cause analysis and solution implementation to enhance the product value streams.
Reviews and approves change proposals and related documentation for compliance with Regulatory approvals and GMP requirements.
Performs Quality review of documents.
How you’ll spend your day
Are you….
Educated to degree Level in Pharmaceutical/ Life Sciences.
Experienced in a regulated environment
Do you have….
Experience managing teams.
Experience in a pharmaceutical Validation, Regulatory or Quality assurance environment.
Experience of Regulatory inspections and customer audits.
Good knowledge and understanding for interpretation of cGMPs and Regulatory requirements.
Good interpersonal and leadership skills to influence team members.
Good knowledge of report writing, Project Management, Continuous Improvement and problem solving tools.
Understanding of production and laboratory systems to effect judgement decisions consistent with quality and business needs.
Knowledge and understanding of validation requirements from process/ cleaning/ packing/ facility aspects/ systems.
